The following Management's Discussion and Analysis of Financial Condition and Results of Operations ("MD&A") is intended to help the reader understand our results of operations and financial condition, cash flows and other changes in financial condition. MD&A is provided as a supplement to, and should be read in conjunction with, our audited consolidated financial statements and the accompanying notes to our consolidated financial statements included in our Annual Report on Form 10-K. This discussion may contain forward-looking statements based upon current expectations that involve risks and uncertainties. Our actual results may differ materially from those anticipated in these forward-looking statements as a result of various factors, including those set forth in Special Note Regarding Forward-Looking Statements included elsewhere in this Quarterly Report on Form 10-Q and in Part I, Item 1A. Risk Factors in our Annual Report on Form 10-K.Royalty Pharma plc is an English public limited company incorporated under the laws ofEngland andWales that was created for the purpose of consolidating our predecessor entities and facilitating the initial public offering ("IPO") of our Class A ordinary shares that was completed inJune 2020 . "Royalty Pharma ," the "Company," "we," "us" and "our" refer toRoyalty Pharma plc and its subsidiaries on a consolidated basis. Business Overview We are the largest buyer of biopharmaceutical royalties and a leading funder of innovation across the biopharmaceutical industry. Since our founding in 1996, we have been pioneers in the royalty market, collaborating with innovators from academic institutions, research hospitals and not-for-profits through small and mid-cap biotechnology companies to leading global pharmaceutical companies. We have assembled a portfolio of royalties which entitles us to payments based directly on the top-line sales of many of the industry's leading therapies, which includes royalties on more than 35 commercial products, including AbbVie and Johnson & Johnson's Imbruvica, Astellas and Pfizer's Xtandi, Biogen's Tysabri, Johnson & Johnson's Tremfya, Gilead'sTrodelvy, Merck & Co.'s Januvia, Novartis' Promacta, Vertex's Kalydeco, Orkambi, Symdeko and Trikafta, and ten development-stage product candidates. We fund innovation in the biopharmaceutical industry both directly and indirectly - directly when we partner with companies to co-fund late-stage clinical trials and new product launches in exchange for future royalties, and indirectly when we acquire existing royalties from the original innovators. Our capital-efficient business model enables us to benefit from many of the most attractive characteristics of the biopharmaceutical industry, including long product life cycles, significant barriers to entry and noncyclical revenues, but with substantially reduced exposure to many common industry challenges such as early stage development risk, therapeutic area constraints, high research and development costs, and high fixed manufacturing and marketing costs. We have a highly flexible approach that is agnostic to both therapeutic area and treatment modality, allowing us to acquire royalties on the most attractive therapies across the biopharmaceutical industry.
We classify our royalty acquisitions by the approval status of the therapy at the time of acquisition:
•Approved Products - We acquire royalties in approved products that generate predictable cash flows and may offer upside potential from unapproved indications. Since inception in 1996 through 2021, we have deployed$15.0 billion of cash to acquire royalties on approved products. From 2012 through 2021, we have acquired$10.2 billion of royalties on approved products.
•Development-Stage Product Candidates - We acquire royalties on
development-stage product candidates that have demonstrated strong clinical
proof of concept. From 2012, when we began acquiring royalties on
development-stage product candidates, through 2021, we have deployed
While we classify our acquisitions in these two broad categories, several of our acquisitions of royalties on approved products were driven by the long-term potential of these products in other, unapproved indications. Similarly, some of our royalty acquisitions in development-stage product candidates are for products that are approved in other indications. 27 --------------------------------------------------------------------------------ROYALTY PHARMA PLC NOTES TO THE CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED) We acquire product royalties in a variety of ways that can be tailored to the needs of our partners. We classify our product royalty acquisitions according to the following structures: •Third-party Royalties - A royalty is the contractual right to a percentage of top-line sales from a licensee's use of a product, technology or intellectual property. The majority of our current portfolio consists of third-party royalties. •Synthetic/Hybrid Royalties - A synthetic royalty is the contractual right to a percentage of top-line sales created by the developer and/or marketer of a therapy in exchange for funding. A synthetic royalty may also include contingent milestone payments, or be structured as a long-term stream of fixed payments with a predetermined schedule. In many of our synthetic royalties, we may also make investments in the public equity of the company, where the main value driver of the company is the product on which we concurrently acquired a royalty. •Development-stage Funding - We have historically funded ongoing research and development ("R&D"), typically for large biopharmaceutical companies, in exchange for future royalties and/or milestones if the product or indication we are funding is approved. We have also made upfront development-stage funding payments to biotechnology companies to acquire royalties and/or milestones on development-stage product candidates. •Mergers and Acquisitions ("M&A") - We acquire royalties in connection with M&A transactions, often from the buyers of biopharmaceutical companies when they dispose of the non-strategic assets of the target company following the closing of the acquisition. We also seek to partner with companies to acquire other biopharmaceutical companies that own significant royalties. We may also seek to acquire biopharmaceutical companies that have significant royalties or where we can create royalties in subsequent transactions.
Background and Format of Presentation
In connection with our IPO, we consummated an exchange offer onFebruary 11, 2020 . Through the exchange offer, investors representing 82% of the aggregate limited partnership in the various partnerships (the "Legacy Investors Partnerships") that own Royalty Pharma Investments, an Irish unit trust ("Old RPI"), exchanged their limited partnership interests in theLegacy Investors Partnerships for limited partnership interests inRPI US Partners 2019, LP, aDelaware limited partnership orRPI International Holdings 2019, LP, aCayman Islands exempted limited partnership (together, the "Continuing Investors Partnerships"). The exchange offer transaction together with (i) the concurrent incurrence of indebtedness under senior credit facilities and (ii) the issuance of additional interests in Continuing Investors Partnerships to satisfy performance payments payable in respect of assets acquired prior to the date of the IPO are referred to as the "Exchange Offer Transactions". Following our IPO, we operate and control the business affairs ofRoyalty Pharma Holdings Ltd , ("RP Holdings ") through our controlling ownership ofRP Holdings' Class A ordinary shares (the "RP Holdings Class A Interests") andRP Holdings' Class B ordinary shares (the "RP Holdings ClassB Interests ").RP Holdings is the sole owner of RPI 2019 ICAV, which is an Irish collective asset management entity formed to facilitate our Exchange Offer Transactions. As a result of the Exchange Offer Transactions, we own, through our subsidiary RPI 2019Intermediate Finance Trust , aDelaware statutory trust ("RPI Intermediate FT"), an 82% economic interest in Old RPI. Through our 82% indirect ownership of Old RPI, we are legally entitled to 82% of the economics of Old RPI's wholly-owned subsidiaries,RPI Finance Trust , aDelaware statutory trust ("RPIFT") andRPI Acquisitions (Ireland), Limited ("RPI Acquisitions"), an Irish private limited company, and 66% ofRoyalty Pharma Collection Trust , aDelaware statutory trust ("RPCT").
The remaining 34% of RPCT is owned by the
Understanding Our Financial Reporting
Most of the royalties we acquire are treated as investments in cash flow streams and are classified as financial assets measured under the effective interest method in accordance with generally accepted accounting principles inthe United States ("GAAP"). Under this accounting methodology, we calculate the effective interest rate on each financial royalty asset using a forecast of the expected cash flows to be received over the life of the financial royalty asset relative to the initial acquisition price. The yield, which is calculated at the end of each reporting period and applied prospectively, is then recognized via accretion into our income at the effective rate of return over the expected life of the financial royalty asset. 28 --------------------------------------------------------------------------------ROYALTY PHARMA PLC NOTES TO THE CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED) The measurement of income from our financial royalty assets requires significant judgments and estimates, including management's judgment in forecasting the expected future cash flows of the underlying royalties and the expected duration of the financial royalty asset. Our cash flow forecasts are generated and updated each reporting period by manually compiling sell-side equity research analysts' consensus sales estimates for each of the products in which we own royalties. We then calculate our expected royalty cash flows using these consensus sales forecasts. In any given reporting period, any decline or increase in the expected future cash flows associated with a financial royalty asset is recognized in our income statement as non-cash provision expense or provision income, respectively. As a result of the non-cash charges associated with applying the effective interest method accounting methodology, our income statement activity can be volatile and unpredictable. Small declines in sell-side equity research analysts' consensus sales forecasts over a long term horizon can result in an immediate non-cash income statement expense recognition which generates a corresponding cumulative allowance that reduces the gross asset balance, even though the applicable cash inflows will not be realized for many years into the future. For example, in late 2014 we acquired the cystic fibrosis franchise royalty and beginning in the second quarter of 2015, declines in near-term sales forecasts of sell-side equity research analysts caused us to recognize non-cash provision expense. Over the course of 10 quarters, we recognized non-cash provision expense as a result of these changes in forecasts including non-cash provision expense of$743.2 million in 2016, ultimately reaching a peak cumulative allowance of$1.30 billion bySeptember 30, 2017 related to this financial royalty asset. With the approval of the Vertex triple combination therapy, Trikafta, inOctober 2019 , sell-side equity research analysts' consensus sales forecasts increased to reflect the larger addressable market and the extension of the expected duration of the Trikafta royalty. While small reductions in the cumulative allowance for the cystic fibrosis franchise were recognized as provision income over the course of 2017 and 2018, there remained a$1.10 billion cumulative allowance that was fully reduced by recognizing provision income of$1.10 billion in 2019 as a result of an increase in sell-side equity research analysts' consensus sales forecasts associated with the Trikafta approval. This example illustrates the volatility caused by our accounting model. In addition, due to the nature of our effective interest methodology, there is no direct correlation between our income from financial royalty assets and our royalty receipts. Therefore, management believes investors should not look to income from royalties and the associated provision for changes in future cash flows as a measure of our near-term financial performance or as a source for predicting future income or growth trends. Our operations have historically been financed primarily with cash flows generated by our royalties. Given the importance of cash flows and their predictability to management's operation of the business, management uses royalty receipts as the primary measure of our operating performance. Royalty receipts refer to the summation of the following line items from our GAAP consolidated statements of cash flows: Cash collections from financial royalty assets, Cash collections from intangible royalty assets, Other royalty cash collections, Proceeds from available for sale debt securities, and Distributions from equity method investees. In addition to analyzing our results on a GAAP basis, management also reviews our results on a non-GAAP basis. The closest comparable GAAP measure to each of the non-GAAP measures that management review is Net cash provided by operating activities. The key non-GAAP metrics we focus on are Adjusted Cash Receipts, Adjusted EBITDA and Adjusted Cash Flow, each of which is further discussed in the section titled "Non-GAAP Financial Results". Adjusted Cash Receipts and Adjusted Cash Flow are used by management as key liquidity measures in the evaluation of our ability to generate cash from operations. Both measures are an indication of the strength of the Company and the performance of the business. Management uses Adjusted Cash Flow to compare its performance against non-GAAP adjusted net income used by companies in the biopharmaceutical industry. Adjusted EBITDA, which is derived from Adjusted Cash Receipts, is used by our lenders to assess our ability to meet our financial covenants.
Refer to the section titled "Non-GAAP Reconciliations" for additional discussion of management's use of non-GAAP measures as supplemental financial measures.
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ROYALTY PHARMA PLC NOTES TO THE CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED) Portfolio Overview Our portfolio consists of royalties on more than 35 marketed therapies and ten development-stage product candidates. The therapies in our portfolio address therapeutic areas such as rare disease, cancer, neurology, infectious disease, hematology and diabetes, and are delivered to patients across both primary and specialty care settings. The table below includes royalty receipts for the three months endedMarch 31, 2022 and 2021 in order of contributions to royalty receipts for the three months endedMarch 31, 2022 (in thousands). For the Three Months Ended March 31, Royalties Marketer(s) Therapeutic Area 2022 2021 Cystic fibrosis franchise (1) Vertex Rare disease$ 201,882 $ 166,809 Tysabri Biogen Neurology 97,439 86,921 Imbruvica AbbVie, Johnson & Johnson Cancer 87,171 89,135 Promacta Novartis Hematology 47,897 44,126 Xtandi Pfizer, Astellas Cancer 43,395 41,045 Januvia, Janumet, Other DPP-IVs (2) Merck & Co., others Diabetes 35,682 35,761 Tremfya Johnson & Johnson Immunology 28,224 - Nurtec ODT/Biohaven payment (3) Biohaven, Pfizer Neurology 20,375 16,501 Cabometyx/Cometriq Exelixis, Ipsen, Takeda Cancer 12,857 - Farxiga/Onglyza AstraZeneca Diabetes 9,469 8,562 Evrysdi Roche Rare disease 9,197 1,677 Trodelvy Gilead Cancer 4,892 2,605 Erleada Johnson & Johnson Cancer 4,886 3,104 Emgality Lilly Neurology 4,764 3,264 Crysvita Ultragenyx, Kyowa Kirin Rare disease 4,712 3,588 Orladeyo BioCryst Rare disease 4,426 12 Prevymis Merck & Co. Infectious disease 4,126 8,630 Oxlumo Alnylam Rare disease 766 - Other products (4) 88,871 137,738 Total royalty receipts$ 711,031 $ 649,478 (1)The cystic fibrosis franchise includes the following approved products: Kalydeco, Orkambi, Symdeko/Symkevi, and Trikafta/Kaftrio. (2)Januvia, Janumet, Other DPP-IVs include the following approved products: Onglyza, Kombiglyze, Galvus, Eucreas and Nesina. The Other DPP-IVs are marketed by AstraZeneca, Novartis and Takeda. (3)Includes royalty receipts for Nurtec ODT of$4.8 million and$0.9 million for the three months endedMarch 31, 2022 and 2021, respectively, and quarterly redemptions of$15.6 million in 2022 and 2021 of the Series A Biohaven Preferred Shares (presented as Proceeds from available for sale debt securities on the statements of cash flows). (4)Other products primarily include royalty receipts on the following products: Bosulif (a product co-developed by our joint venture investee, Avillion,I, for which receipts are presented as Distributions from equity method investees on the statements of cash flows), Cimzia, Entyvio, HIV franchise, IDHIFA, Letairis, Lexiscan, Mircera, Myozyme, Nesina, Soliqua, Tazverik and contributions from the Legacy SLP Interest (defined below). 30 -------------------------------------------------------------------------------- ROYALTY PHARMA PLC NOTES TO THE CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED) Financial Overview Financial Highlights •Net cash provided by operating activities totaled$460.3 million and$526.1 million for the three months endedMarch 31, 2022 and 2021, respectively. Net cash provided by operating activities is the closest comparable GAAP financial measure to the supplemental non-GAAP liquidity measures that follow. •Adjusted Cash Receipts (a non-GAAP metric) totaled$604.6 million and$523.8 million for the three months endedMarch 31, 2022 and 2021, respectively. •Adjusted EBITDA (a non-GAAP metric) totaled$555.7 million and$481.6 million for the three months endedMarch 31, 2022 and 2021, respectively. •Adjusted Cash Flow (a non-GAAP metric) totaled$367.1 million and$409.3 million for the three months endedMarch 31, 2022 and 2021, respectively.
Understanding Our Results of Operations
We report non-controlling interests related to the portion of ownership interests of consolidated subsidiaries not owned by us which are attributable to:
1. The Legacy Investors Partnerships' 18% ownership interest in Old RPI. The value of this non-controlling interest will decline over time as the assets in Old RPI expire. 2. The RP Holdings ClassB Interests held indirectly by the Continuing Investors Partnerships, which represent an approximate 28% ownership interest inRP Holdings as ofMarch 31, 2022 and are exchangeable for our Class A ordinary shares. The value of this non-controlling interest will decline over time if the investors who indirectly own the RP Holdings ClassB Interests conduct exchanges for our Class A ordinary shares.
3. A de minimis interest in RPCT held by RPSFT as a result of a 2011 reorganization transaction. The value of this non-controlling interest will decline over time as the royalty assets owned by RPCT expire and is expected to be substantially eliminated by the end of 2022.
4. The RP Holdings Class C ordinary share (the "RP Holdings ClassC Special Interest") held byRPI EPA Holdings, LP ("EPA Holdings "), an affiliate of the Manager. Income will not be allocated to this non-controlling interest until certain conditions are met.
All of the results of operations of
Following the IPO,EPA Holdings is entitled to receive Equity Performance Awards through its RP Holdings ClassC Special Interest. Equity Performance Awards owed toEPA Holdings will be recognized as an equity transaction when the obligation becomes due and will impact the income allocated to non-controlling interest related to the RP Holdings ClassC Special Interest at that time. The Equity Performance Awards will be payable in RP Holdings ClassB Interests for which we will issue the same number of our Class B ordinary shares, which may be subsequently exchanged for our Class A ordinary shares. We do not currently expect any material Equity Performance Awards to be payable until certain performance conditions are met, which we do not expect to occur until the mid-2020s.
Total income and other revenues
Total income and other revenues is primarily comprised of income from our financial royalty assets, royalty revenue from our intangible royalty assets, and royalty income generally arising from successful commercialization of products developed through joint R&D funding arrangements. Most of our royalties on both approved products and development-stage product candidates that are not accounted for as R&D funding expense are classified as financial assets as our ownership rights are generally passive in nature. In instances in which we acquire a royalty that does include more substantial rights or ownership of the underlying intellectual property, we classify such royalties as intangible assets. 31 -------------------------------------------------------------------------------- ROYALTY PHARMA PLC NOTES TO THE CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED) We recognize interest income related to our financial royalty assets. Royalty revenue relates solely to revenue from our DPP-IV patent estate for which the patent rights have been licensed to various counterparties. For the three months endedMarch 31, 2022 and 2021, the royalty payors accounting for greater than 10% of our total income and other revenues in any one period are shown in the table below: For the Three Months Ended March 31, Royalty Payor Royalties 2022 2021 Vertex Cystic fibrosis franchise 35 % 32 % AbbVie Imbruvica 16 % 17 % HIV franchise, Letairis, Lexiscan, Gilead Trodelvy * 12 %
* Represents less than 10%.
Income from financial royalty assets
Our financial royalty assets represent investments in cash flow streams with yield components that most closely resemble loans measured at amortized cost under the effective interest method. We calculate the effective interest rate using forecasted expected cash flows to be received over the life of the royalty asset relative to the initial acquisition price. Interest income is recognized at the effective rate of return over the expected life of the asset, which is calculated at the end of each reporting period and applied prospectively. As changes in sell-side equity research analysts' consensus sales estimates are updated on a quarterly basis, the effective rate of return changes. For example, if sell-side equity research analysts' consensus sales forecasts increase, the yield to derive income on a financial royalty asset will increase and result in higher income for subsequent periods. Variables affecting the recognition of interest income from financial royalty assets on individual products under the prospective effective interest method include any one of the following: (1) additional acquisitions, (2) changes in expected cash flows of the underlying pharmaceutical products, derived primarily from sell-side equity research analysts' consensus sales forecasts, (3) regulatory approval of additional indications which leads to new cash flow streams, (4) changes to the estimated duration of the royalty (i.e., patent expiration date) and (5) changes in amounts and timing of projected royalty receipts and milestone payments. Our financial royalty assets are directly linked to sales of underlying pharmaceutical products whose life cycle typically peaks at a point in time, followed frequently by declining sales trends due to the entry of generic competition, resulting in natural declines in the asset balance and periodic interest income over the life of our royalties. The recognition of interest income from royalties requires management to make estimates and assumptions around many factors, including those impacting the variables noted above.
Revenue from intangible royalty assets
Revenue from intangible royalty assets is derived from sales of Januvia, Janumet and other DPP-IV products by our licensees. Our royalties on Januvia and Janumet expired in the three months endedMarch 31, 2022 . Our royalties on other DPP-IVs have also substantially ended and we do not expect any material revenue from our DPP-IV intangible assets in the future periods.
Other royalty income
Other royalty income primarily includes income from financial royalty assets that have been fully amortized by the expected expiry date and royalty income from synthetic royalties arising out of R&D funding arrangements. Occasionally, a royalty asset may be amortized on an accelerated basis due to collectability concerns, which, if resolved, may result in future cash collections when no financial royalty asset remains. Similarly, we may continue to collect royalties on a financial royalty asset beyond the estimated duration by which the financial asset was fully amortized. In each scenario where a financial royalty asset has been fully amortized, income from such royalty is recognized as Other royalty income. 32 --------------------------------------------------------------------------------ROYALTY PHARMA PLC NOTES TO THE CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)
Provision for changes in expected cash flows from financial royalty assets
The Provision for changes in expected future cash flows from financial royalty assets includes the following:
•expense or income related to the current period activity resulting from adjustments to the cumulative allowance for changes in expected cash flows; and •expense or income related to the provision for current expected credit losses, which reflects the activity for the period, primarily due to new financial royalty assets with limited protective rights and changes to cash flow estimates for financial royalty assets with limited protective rights. As discussed above, income is accreted on our financial royalty assets using the effective interest method. As we update our forecasted cash flows on a periodic basis and recalculate the present value of the remaining future cash flows, any shortfall when compared to the carrying value of the financial royalty asset is recorded directly to the income statement through the line item Provision for changes in expected cash flows from financial royalty assets. If, in a subsequent period, there is an increase in expected cash flows or if actual cash flows are greater than cash flows previously expected, we reduce the cumulative allowance previously established for a financial royalty asset for the incremental increase in the present value of cash flows expected to be collected. This results in provision income (i.e., a credit to the provision). Most of the same variables and management's estimates affecting the recognition of interest income on our financial royalty assets also impact the provision. In any period, we will recognize provision income or expense as a result of the following factors: (1) changes in expected cash flows of the underlying pharmaceutical products, derived primarily from sell-side equity research analysts' consensus sales forecasts, (2) regulatory approval of additional indications which leads to new cash flow streams, (3) changes to the estimated duration of the royalty (i.e., patent expiration date) and (4) changes in amounts and timing of projected royalty receipts and milestone payments.
R&D funding expense
R&D funding expense consists of upfront and ongoing development-stage funding payments we have made to counterparties to acquire royalties and/or milestones on development-stage product candidates. Upfront development-stage funding expense includes payments made at the close of acquisitions and subsequent milestone payments. Ongoing development-stage funding payments are made as the related product candidates undergo clinical trials with our counterparties. These expenditures relate to the activities performed by our counterparties to develop and test new products, to test existing products for treatment in new indications, and to ensure product efficacy and regulatory compliance prior to launch.
General and administrative expenses
General and administrative ("G&A") expenses include primarily Operating and Personnel Payments (defined below), legal expenses, other expenses for professional services and share-based compensation. The expenses incurred in respect of Operating and Personnel Payments are expected to comprise the most significant component of G&A expenses on an ongoing basis. Under the management agreement that became effective onFebruary 11, 2020 (the "Management Agreement"), we pay quarterly operating and personnel expenses to the Manager or its affiliates ("Operating and Personnel Payments") equal to 6.5% of the cash receipts from royalty investments for each quarter and 0.25% of the value of our security investments under GAAP as of the end of each quarter. The operating and personnel payments for Old RPI, an obligation of the Legacy Investors Partnerships as a non-controlling interest in Old RPI and for which the expense is reflected in G&A expenses, are calculated as the greater of$1 million per quarter and 0.3125% of royalties from Royalty Investments (as defined in the limited partnership agreements of theLegacy Investors Partnerships) during the previous twelve calendar months. 33 --------------------------------------------------------------------------------ROYALTY PHARMA PLC NOTES TO THE CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)
Equity in (earnings)/losses of equity method investees
Equity in (earnings)/losses of equity method investees primarily includes the results of our share of income or loss from the following non-consolidated affiliates:
1. Legacy SLP Interest. In connection with the Exchange Offer Transactions, we acquired an equity method investment from the Continuing Investors Partnerships in the form of a special limited partnership interest in theLegacy Investors Partnerships (the "Legacy SLP Interest") in exchange for issuing shares in our subsidiary. The Legacy SLP Interest entitles us to the equivalent of performance distribution payments that would have been paid to the general partner of the Legacy Investors Partnerships and a performance income allocation on a similar basis. As the Legacy Investors Partnerships no longer participate in investment opportunities, the value of the Legacy SLP Interest is expected to decline over time. 2. The Avillion Entities. The Avillion entities (as defined below) partner with global biopharmaceutical companies to perform R&D in exchange for success-based milestones and/or royalties once products are commercialized. Our investments inAvillion Financing I, LP ("Avillion I") andBAv Financing II, LP ("Avillion II", or, together with Avillion I, the "Avillion Entities") are accounted for using the equity method. Other expense, net Other expense, net primarily includes the change in fair market value of our equity securities and the unrealized gains and losses on our available for sale debt securities, including related forwards and funding commitments, and interest income.
Net income attributable to non-controlling interests
The net income attributable to non-controlling interests includes the Legacy Investors Partnerships' approximately 18% share of earnings in Old RPI. As the Legacy Investors Partnerships no longer participate in investment opportunities, the related net income attributable to this non-controlling interest is expected to decline over time. Net income attributable to non-controlling interests includes theRP Holdings ClassB Interests held by the Continuing Investors Partnerships and will include net income attributable to the RP Holdings ClassC Special Interest held byEPA Holdings once certain conditions have been met. Future net income attributable to the non-controlling interest related to the RP Holdings ClassB Interests held by the Continuing Investors Partnerships will decline over time if the investors who indirectly own the RP Holdings ClassB Interests conduct exchanges for our Class A ordinary shares. Net income attributable to non-controlling interests also includes RPSFT's 20% share of earnings in RPCT, which is a consolidated subsidiary of Old RPI. We expect net income attributable to this non-controlling interest to decline over time as the royalty assets owned by RPCT expire and to be substantially eliminated by the end of 2022.
Net income attributable to non-controlling interests above can fluctuate significantly from period to period, primarily driven by volatility in the income statement activity of the respective underlying entity as a result of the non-cash charges associated with applying the effective interest accounting methodology as described in section titled "Understanding Our Financial Reporting".
34 --------------------------------------------------------------------------------ROYALTY PHARMA PLC NOTES TO THE CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)
Results of Operations
For the Three Months Ended
The comparison of our historical results of operations for the three months
ended
(in thousands) For the Three Months Ended March 31, 2022 vs. 2021 Change 2022 2021 $ % Income and other revenues: Income from financial royalty assets$ 511,523 $ 529,625 $ (18,102) (3.4) % Revenue from intangible royalty assets 33,586 36,061 (2,475) (6.9) % Other royalty income 16,940 7,341 9,599 130.8 % Total income and other revenues 562,049 573,027 (10,978) (1.9) % Operating expenses: Provision for changes in expected cash flows from financial royalty assets 184,621 292,262 (107,641) (36.8) % Research and development funding expense 100,500 2,641 97,859 * Amortization of intangible assets 5,670 5,671 (1) 0.0 % General and administrative expenses 51,540 43,156 8,384 19.4 % Total operating expenses, net 342,331 343,730 (1,399) (0.4) % Operating income 219,718 229,297 (9,579) (4.2) % Other (income)/expense: Equity in (earnings)/losses of equity method investees (397) 1,918 (2,315) (120.7) % Interest expense 47,063 37,415 9,648 25.8 % Other expense, net 44,969 30,985 13,984 45.1 % Total other expenses, net 91,635 70,318 21,317 30.3 % Consolidated net income 128,083 158,979 (30,896) (19.4) % Net income attributable to non-controlling interests 76,322 89,860 (13,538) (15.1) % Net income attributable to Royalty Pharma plc$ 51,761 $ 69,119 $ (17,358) (25.1) %
*Percentage change is not meaningful.
Total income and revenues
Income from financial royalty assets
Income from financial royalty assets by top products for the three months endedMarch 31, 2022 and 2021 is as follows, in order of contribution to income for the three months endedMarch 31, 2022 : (in thousands) For the Three Months Ended March 31, 2022 vs. 2021 Change 2022 2021 $ % Cystic fibrosis franchise$ 194,457 $ 184,816 $ 9,641 5.2 % Imbruvica 87,627 99,115 (11,488) (11.6) % Tysabri 52,521 51,098 1,423 2.8 % Xtandi 24,917 26,980 (2,063) (7.6) % Promacta 20,804 16,284 4,520 27.8 % Evrysdi 18,088 14,426 3,662 25.4 % Other 113,109 136,906 (23,797) (17.4) % Total income from financial royalty assets$ 511,523 $ 529,625 $ (18,102) (3.4) % 35
--------------------------------------------------------------------------------ROYALTY PHARMA PLC NOTES TO THE CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)
Three months ended
Income from financial royalty assets decreased by$18.1 million , or 3.4%, in the three months endedMarch 31, 2022 compared to the three months endedMarch 31, 2021 , primarily driven by declines in sell-side equity research analysts' consensus sales forecasts for Imbruvica and the maturity of our royalties from the HIV franchise. The decrease in income was partially offset by income related to newly acquired assets, primarily Tremfya, Cabometyx/Cometriq and Oxlumo, for which there was no comparable activity in the three months endedMarch 31, 2021 .
Revenue from intangible royalty assets
Three months ended
Revenue from intangible royalty interests was relatively flat in the three
months ended
Other royalty income
Three months ended
Other royalty income increased by$9.6 million , or 130.8%, in the three months endedMarch 31, 2022 compared to the three months endedMarch 31, 2021 , primarily related to growth in the ongoing product launches of Nurtec ODT and Trodelvy that arose from our R&D funding agreements with Biohaven and Immunomedics, respectively. Other royalty income in the three months endedMarch 31, 2022 also includes income from Letairis, a fully amortized financial royalty asset, but for which we expect minimal residual royalty income.
Provision for changes in expected cash flows from financial royalty assets
The breakdown of our provision for changes in expected future cash flows includes the following: •expense or income related to the current period activity resulting from adjustments to the cumulative allowance for changes in expected cash flows; and •expense or income related to the provision for current expected credit losses. As the provision activity is a combination of income and expense items, the provision breakdown by royalty, exclusive of the provision for current expected credit losses, is as follows, based on the largest contributors to each period's provision income or expense: (in thousands) For the Three For the Three Months Ended Months Ended March 31, March 31, Royalty 2022 Royalty 2021 Imbruvica$ 108,910 Imbruvica$ 63,414 Tazverik 64,356 Cystic fibrosis franchise 53,092 IDHIFA 38,491 Tazverik 48,422 Xtandi 24,857 Xtandi 42,852 Cystic fibrosis franchise (48,636) Emgality 35,236 Other 46,224 Other 13,305 Total provision, exclusive of 234,202 Total provision, exclusive of 256,321 provision for credit losses provision for credit losses Provision for current expected (49,581) Provision for current expected 35,941 credit losses credit losses Total provision expense$ 184,621 Total provision expense$ 292,262 36
--------------------------------------------------------------------------------ROYALTY PHARMA PLC NOTES TO THE CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)
Three months ended
In the three months endedMarch 31, 2022 , we recorded provision expense of$184.6 million , comprised of$234.2 million in provision expense for changes in expected cash flows and$49.6 million in provision income for current expected credit losses. We recorded provision expense for Imbruvica and Tazverik, primarily due to significant declines in sell-side equity research analysts' consensus sales forecasts partially offset by provision income for the cystic fibrosis franchise due to a significant increase in sell-side equity research analysts' consensus sales forecasts. During the three months endedMarch 31, 2022 , the provision income for credit losses was primarily driven by a significant decrease in current expected credit losses related to Tazverik as a result of the corresponding significant decline in the financial asset value. In the three months endedMarch 31, 2021 , we recorded provision expense of$292.3 million , of which$256.3 million and$35.9 million related to provision expense for changes in expected cash flows and current expected credit losses, respectively. We recorded provision expense for Imbruvica, the cystic fibrosis franchise, Tazverik, Xtandi and Emgality, primarily due to declines in sell-side equity research analysts' consensus sales forecasts. During the three months endedMarch 31, 2021 , the provision expense for current expected credit losses was primarily driven by increases to our portfolio of financial royalty assets, including the incremental$100 million financial royalty asset related to zavegepant and a new royalty interest in Cabometyx/Cometriq.
R&D funding expense
Three months ended
R&D funding expense increased by$97.9 million in the three months endedMarch 31, 2022 as compared to the three months endedMarch 31, 2021 , primarily driven by upfront and milestone development-stage funding payments of$100.0 million to Cytokinetics to acquire a royalty on a development-stage product in the three months endedMarch 31, 2022 . G&A expenses
Three months ended
G&A expenses increased by
Equity in (earnings)/losses of equity method investees
Three months ended
Equity in earnings of equity method investees was
Equity in earnings from the Legacy SLP Interest was$4.5 million and$5.2 million , in the three months endedMarch 31, 2022 and 2021, respectively. Equity in losses of the Avillion entities was$4.1 million and$7.1 million in the three months endedMarch 31, 2022 and 2021, respectively.
Interest expense
Three months ended
Interest expense increased by$9.6 million , or 25.8%, in the three months endedMarch 31, 2022 as compared to the three months endedMarch 31, 2021 , primarily driven by the issuance of$1.3 billion senior unsecured notes inJuly 2021 ("2021 Notes"). The weighted average coupon rate was 2.245% and 2.125% in the three months endedMarch 31, 2022 and 2021, respectively.
Refer to the "Liquidity and Capital Resources" section for additional discussion of the 2021 Notes.
37 --------------------------------------------------------------------------------ROYALTY PHARMA PLC NOTES TO THE CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)
Other expense, net
Three months ended
Other expense, net of$45.0 million in the three months endedMarch 31, 2022 , was primarily comprised of losses on equity securities of$36.2 million driven by a net decrease in the share price of our investees and losses on available for sale debt securities of$16.6 million , offset by interest income of$9.5 million primarily related to our Series A Biohaven Preferred Shares. The$16.6 million in unrealized losses on available for sales debt securities included a loss of$10.2 million related to the unrealized movement in fair value of the MorphoSys Development Funding Bond Forward for which there was no comparable activity in the prior period. Other expense, net was$31.0 million in the three months endedMarch 31, 2021 , primarily comprised of losses on equity securities of$54.2 million driven a decreased share price of our investees. The decrease was partially offset by interest income of$16.6 million , primarily related to our Series A Biohaven Preferred Shares and a gain of$9.1 million related to the unrealized movement in fair value of the Series B Biohaven Preferred Shares and related Series B Forwards recorded as Available for sale debt securities.
Net income attributable to non-controlling interests
Three months ended
Net income attributable to the Legacy Investors Partnerships increased by$14.3 million in the three months endedMarch 31, 2022 as compared to the three months endedMarch 31, 2021 , primarily driven by higher net income attributable to Old RPI. Net income attributable to the Continuing Investors Partnerships decreased by$17.9 million in the three months endedMarch 31, 2022 as compared to the three months endedMarch 31, 2021 , primarily driven by lower net income attributable toRP Holdings in the three months endedMarch 31, 2022 . The ongoing exchanges by investors in the Continuing Investors Partnerships who indirectly own the RP Holdings ClassB Interests for our Class A ordinary shares resulted in a decline in the Continuing Investors Partnerships' ownership ofRP Holdings . Net income attributable to RPSFT decreased by$9.9 million in the three months endedMarch 31, 2022 as compared to the three months endedMarch 31, 2021 . We expect net income attributable to RPSFT to continue to decline as the assets held by RPCT mature.
Key Developments and Upcoming Events Relating to Our Portfolio
The key developments impacting our cash receipts and income and revenue from our royalty interests are discussed below:
Commercial Products
•Cystic fibrosis franchise. InApril 2021 , Vertex announcedEuropean Commission ("EC") approval for Kaftrio in combination with ivacaftor for the treatment of patients with cystic fibrosis ages 12 and older who have at least one F508del mutation. InJune 2021 , Vertex announced thatU.S. Food and Drug Administration ("FDA") approved Trikafta for the treatment of children with cystic fibrosis ages 6 through 11 who have at least one F508del mutation or have certain mutations that are responsive to Trikafta based on in vitro data. InJanuary 2022 , Vertex announced that the EC granted approval for the label expansion of Kaftrio in combination with ivacaftor for the treatment of cystic fibrosis in patients ages 6 through 11 years old who have at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator gene. 38 --------------------------------------------------------------------------------ROYALTY PHARMA PLC NOTES TO THE CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED) •Tysabri. InApril 2021 , Biogen announced that the EC granted marketing authorization for a subcutaneous injection of Tysabri to treat relapsing-remitting multiple sclerosis. Biogen also announced that it had received a Complete Response Letter from the FDA for its sBLA for subcutaneous Tysabri. The Complete Response Letter indicates that the FDA is unable to approve Biogen's filing as submitted. Biogen announced that it is evaluating the Complete Response Letter and will determine next steps inthe United States . InAugust 2021 , Biogen announced results from Phase 3b NOVA study evaluation every six-week dosing with Tysabri intravenous administration in relapsing-remitting multiple sclerosis. Results show that every six-week Tysabri intravenous administration provides a high level of efficacy in controlling multiple sclerosis disease activity in patients who switched from the approved every four-week dosing regimen. •Imbruvica. InJune 2021 , AbbVie announced Phase 3 GLOW study results for Imbruvica in combination with Venetoclax for the treatment of first-line CLL and SLL demonstrated superior progression-free survival versus chlorambucil plus obinutuzumab as a first-line treatment of CLL. The study also showed improved duration of remission and significantly improved depth of remission. AbbVie has indicated that approval could occur in 2022. InAugust 2021 , AbbVie announced that theU.S. District Court for the District of Delaware had issued a decision holding patent rights relating to Imbruvica were valid and infringed by a generic product from Alvogen and Natco. The decision, which is subject to appeal, prohibits regulatory approval of that generic product until the last AbbVie patent expires. Previously, AbbVie entered into several settlement and license agreements with other generic companies. Consequently, AbbVie does not expect any generic product entry prior toMarch 30, 2032 , assuming pediatric exclusivity is granted.
•Xtandi. In
InSeptember 2021 , Astellas Pharma and Pfizer announced that Xtandi plus androgen deprivation therapy (ADT) reduced the risk of death by 34% compared to placebo plus ADT in the Phase 3ARCHES study in men with metastatic hormone-sensitive prostate cancer. The primary results from theARCHES trial were published in 2019. Astellas and Pfizer have indicated that there could be a potential readout of the Phase 3 EMBARK trial for high-risk non-metastatic prostate cancer in the second half of 2022. •Nurtec ODT. InMay 2021 , Biohaven announced that the FDA approved Nurtec ODT for the preventative treatment of migraine, indicated for adult patients with episodic migraine who experience less than 15 headache days per month. InNovember 2021 , Biohaven announced a strategic collaboration with Pfizer for the commercialization of rimegepant outsidethe United States . Pfizer also gains rights outsidethe United States to zavegepant, which is being studied in an intranasal delivery and an oral formulation in Phase 3 clinical trials for migraine indications. InApril 2022 , Pfizer and Biohaven announced that the EC has granted marketing authorization for Vydura (rimegepant) for both the acute treatment of migraine with or without aura, and prophylaxis of episodic migraine in adults who have at least four migraine attacks per month.The EC approval will be valid for all 27European Union member states as well asIceland ,Liechtenstein andNorway and local reimbursement approval will follow. •Trodelvy. InApril 2021 , Gilead announced the FDA granted full approval to Trodelvy for adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) who have received two or more prior systemic therapies, at least one of them for metastatic disease. The approval is supported by data from the Phase 3 ASCENT study. InApril 2021 , Gilead announced that the FDA granted an accelerated approval of Trodelvy for use in adult patients with locally advanced or metastatic urothelial cancer who have previously received a platinum-containing chemotherapy and either a programmed death receptor-1 or a programmed death-ligand 1 inhibitor. The accelerated approval was based on data from the international Phase 2, single-arm TROPHY study. 39 --------------------------------------------------------------------------------
ROYALTY PHARMA PLC NOTES TO THE CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED) InJune 2021 , Gilead announced superior outcomes to standard of care in second-line treatment of metastatic TNBC in the Phase 3 ASCENT study. Trodelvy more than doubled overall survival as a second-line treatment in the new ASCENT subgroup analysis.
In
InNovember 2021 , Gilead announced that the EC granted marketing authorization for Trodelvy as a monotherapy indicated for the treatment of adult patients with unresectable or metastatic TNBC who have received two or more prior systemic therapies, at least one of them for advanced disease.The EC's decision is supported by results from the Phase 3 ASCENT study, where Trodelvy reduced the risk of death by 49% and improved median overall survival to 11.8 months versus 6.9 months with physician's choice of chemotherapy. InJanuary 2022 , Gilead announced it has entered into two clinical trial collaboration and supply agreements with Merck & Co. to evaluate the combination of Trodelvy and Merck & Co.'s anti-PD-1 therapy Keytruda in first-line metastatic non-small cell lung cancer (NSCLC). As part of the collaboration, Merck & Co. will sponsor a global Phase 3 clinical trial of Trodelvy in combination with Keytruda as a first-line treatment of patients with metastatic NSCLC. Additionally, Gilead and Merck & Co. recently established an agreement where Gilead will sponsor a Phase 2 signal-seeking study evaluating combinations that include pembrolizumab in first-line NSCLC. InMarch 2022 , Gilead announced results from the Phase 3 TROPiCS-02 study evaluating Trodelvy in patients with HR+/HER2- metastatic breast cancer who received prior endocrine therapy, CDK4/6 inhibitors and two to four lines of chemotherapy met its primary endpoint with a statistically significant improvement in progression-free survival versus physician's choice of chemotherapy. The trial targeted a 30% reduction in the risk of disease progression or death and the primary endpoint results were consistent with those observed in the Phase 1/2 IMMU-132-01 study in a subset of HR+/HER2- metastatic breast cancer patients. The first interim analysis of the key secondary endpoint of overall survival demonstrated a trend in improvement for overall survival. Patients will be followed for a subsequent overall survival analysis. The safety profile for Trodelvy was consistent with prior studies. •Cabometyx. InJanuary 2021 , Exelixis announced that the FDA approved Cabometyx for patients with advanced renal cell carcinoma (RCC) as a first-line treatment in combination with Bristol Myers Squibb's Opdivo. The approval was based on the Phase 3 CheckMate -9ER trial, in which the combination of Cabometyx and Opdivo significantly improved overall survival while doubling progression-free survival and objective response rate versus sunitinib as a first-line treatment for patients with advanced RCC.
In
InAugust 2021 , Exelixis announced that their partners Takeda and Ono received approval inJapan for Cabometyx in combination with Opdivo for the treatment of unresectable or metastatic RCC. InSeptember 2021 , Exelixis announced detailed results from the expanded Cohort 6 of the Phase 1b COSMIC-021 trial of Cabometyx in combination with atezolizumab in patients with metastatic CRPC, which included patients with metastatic CRPC who had been previously treated with novel hormone therapies enzalutamide and/or abiraterone acetate used along with prednisone. Following discussions with FDA, Exelixis will not pursue a regulatory submission for the combination regimen based on cohort 6 of COSMIC-021. CONTACT-02, a global Phase 3 pivotal trial that initiated enrollment inJune 2020 may serve as a basis for future regulatory applications. InSeptember 2021 , Exelixis announced FDA approved Cabometyx for patients with previously treated radioactive iodine-refractory differentiated thyroid cancer. The approval was based on the Phase 3 COSMIC-311 pivotal trial. 40 --------------------------------------------------------------------------------ROYALTY PHARMA PLC NOTES TO THE CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED) InMarch 2022 , Exelixis announced results from the final analysis of the second primary endpoint of overall survival from the Phase 3 COSMIC-312 trial, which evaluated cabozantinib in combination with atezolizumab versus sorafenib in patients with previously untreated advanced hepatocellular carcinoma. The final analysis showed neither improvement nor detriment in overall survival for cabozantinib in combination with atezolizumab versus sorafenib. Exelixis has indicated it expects Phase 3 data from the COSMIC-313 trial in 1L RCC in the first half of 2022 and initial Phase 3 data in the second half of 2022 from CONTACT-01 in metastatic NSCLC and CONTACT-03 in advanced or metastatic RCC. •Evrysdi. InMarch 2021 , Roche announced that the EC approved Evrysdi for the treatment of spinal muscular atrophy (SMA) in patients two months of age and older, with a clinical diagnosis of SMA Type 1, Type 2 or Type 3 or with one to four splicing modifier of motor neuron 2 copies.
In
•Orladeyo. InJanuary 2021 , Orladeyo was approved inJapan , becoming the first and only prophylactic hereditary angioedema (HAE) medication approved in the region.
In
In
•Oxlumo. InJuly 2021 , Alnylam announced results from ILLUMINATE-C, a Phase 3 open-label study of lumasiran in patients of all ages with advanced primary hyperoxaluria type 1 associated with progressive decline in renal function. Results from the primary analysis at six months demonstrated a substantial reduction in plasma oxalate from baseline in patients with advanced disease, including those on hemodialysis. The safety and tolerability profile of lumasiran following six months of treatment was encouraging across all ages, with no drug related serious adverse events and injection site reactions as the most common adverse event. InMarch 2022 , the FDA accepted Alnylam's supplemental New Drug Application for lumasiran for the reduction of plasma oxalate in the treatment of patients with advanced primary hyperoxaluria type 1. The FDA has set an action date forOctober 6, 2022 . Additionally, a Type II Variation for lumasiran to amend the label in patients with advanced Primary Hyperoxaluria Type 1 was submitted and validated by theEuropean Medicines Agency ("EMA") inDecember 2021 . •Tremfya. InFebruary 2022 , Johnson & Johnson announced results from the Phase 2a VEGA proof-of-concept study. Results showed that the combination of Tremfya and golimumab, a tumor necrosis factor-alpha antagonist, induced higher rates of clinical response, clinical remission, endoscopic improvement and a composite histologic-endoscopic endpoint at 12 weeks than either treatment alone in adults with moderately to severely active ulcerative colitis. Rates of adverse events were comparable among treatment groups. InFebruary 2022 , Johnson & Johnson announced results from the Phase 2b QUASAR Induction Study 1. Results showed that a significantly greater proportion of adults with moderately to severely active ulcerative colitis who previously had an inadequate response or intolerance to conventional therapies and/or selected advanced therapies and were treated with Tremfya achieved clinical response at week 12 (Tremfya 200mg: 61.4% and Tremfya 400mg: 60.7%), the study's primary endpoint, compared with placebo (27.6%). Safety data at week 12 were consistent with the safety profile for Tremfya in approved indications. 41 --------------------------------------------------------------------------------ROYALTY PHARMA PLC NOTES TO THE CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)
Development-Stage Product Candidates
•Aficamten. In
InFebruary 2022 , Cytokinetics announced positive topline results from Cohort 3 of the REDWOOD-HCM Phase 2 trial. Results from Cohort 3 showed that substantial reductions in the average resting left ventricular outflow tract pressure gradient (LVOT-G) as well as the post-Valsalva LVOT-G were achieved for patients with oHCM and a resting or post-Valsalva LVOT-G of ?50 mmHg whose background therapy included disopyramide and in the majority a beta-adrenergic blocker. The safety and tolerability of aficamten were consistent with prior experience in REDWOOD-HCM with no treatment interruptions and no serious adverse events attributed to treatment reported by the investigators. •BCX9930. InApril 2022 , BioCryst announced that it is pausing enrollment in clinical trials with BCX9930, while BioCryst investigates elevated serum creatinine levels seen in some patients. BioCryst will not enroll new patients in the REDEEM-1, REDEEM-2 or RENEW clinical trials during the investigation. Patients currently enrolled in the trials are continuing on the study drug. •Gantenerumab. InOctober 2021 , Roche announced that gantenerumab, an anti-amyloid beta antibody developed for subcutaneous administration, has been granted Breakthrough Therapy Designation by the FDA for the treatment of people living with Alzheimer's disease. This designation is based on data showing that gantenerumab significantly reduced brain amyloid plaque, a pathological hallmark of Alzheimer's disease, in the ongoing SCarlet RoAD and Marguerite RoAD open-label extension trials, as well as other studies. InMarch 2022 , Roche announced a new Phase 3 Alzheimer's disease prevention trial (SKYLINE). Roche intends to enter into a collaboration agreement with Banner Alzheimer's Institute's Alzheimer's Prevention Initiative,Massachusetts General Hospital and theUniversity of Southern California Alzheimer's Therapeutic Research Institute to further exchange scientific insights and advance the trial goals. SKYLINE aims to evaluate the potential of gantenerumab to slow disease progression in people with the earliest biologic signs of Alzheimer's disease and who show no signs of cognitive impairment.
Roche has indicated it expects Phase 3 data from the GRADUATE 1/2 trial in Alzheimer's disease in the fourth quarter of 2022.
•Omecamtiv mecarbil. InFebruary 2022 , Cytokinetics announced that FDA has accepted and filed the company's New Drug Application (NDA) for omecamtiv mecarbil. The FDA assigned the NDA a standard review with a PDUFA target action date ofNovember 30, 2022 . The FDA also indicated that it is currently not planning to hold an advisory committee meeting to discuss the application. The submission is supported by GALACTIC-HF, which demonstrated a positive effect on the primary composite endpoint of cardiovascular death or heart failure events in patients with heart failure and reduced ejection fraction who were receiving standard of care plus omecamtiv mecarbil. InFebruary 2022 , Cytokinetics announced results from METEORIC-HF, a Phase 3 trial evaluating the effect of treatment with omecamtiv mecarbil compared to placebo on exercise capacity in patients with heart failure with reduced ejection fraction. After 20 weeks of treatment, there was no change in peak oxygen uptake in patients treated with omecamtiv mecarbil versus placebo.
•Otilimab. GlaxoSmithKline has indicated it expects Phase 3 data from the contRast trials in rheumatoid arthritis in the second half of 2022.
42 -------------------------------------------------------------------------------- ROYALTY PHARMA PLC NOTES TO THE CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED) •Pelabresib. InDecember 2021 , MorphoSys presented the latest data from the Phase 2 MANIFEST study evaluating pelabresib in the treatment of myelofibrosis. As ofSeptember 10, 2021 , the data cut-off, a total of 84 JAK inhibitor-naive patients were enrolled and received the first-line combination of pelabresib and ruxolitinib. The data showed 68% (n=57) of patients treated with the combination achieved a greater than or equal to 35% reduction in spleen volume (SVR35) from baseline at week 24 and 60% (n=47) maintained SVR35 at week 48. Most patients also saw their symptoms reduced, with 56% (n=46) achieving greater than or equal to 50% reduction in total symptom score from baseline at week 24. •PT027. InSeptember 2021 , AstraZeneca and Avillion announced positive results from MANDALA and DENALI, two Phase 3 trials evaluating PT027 (albuterol/budesonide) in patients with asthma. PT027 is a potential first-in-class inhaled, fixed-dose combination of albuterol, a short-acting beta2-agonist, and budesonide, an inhaled corticosteroid. In MANDALA, PT027 demonstrated a statistically significant and clinically meaningful reduction in the risk of severe exacerbations compared to albuterol, when used as a rescue medicine in response to symptoms. In DENALI, PT027 showed a statistically significant improvement in lung function measured by forced expiratory volume in one second, compared to the individual components albuterol and budesonide, and compared to placebo. The safety and tolerability of PT027 in both trials was consistent with the known profiles of the components. AstraZeneca has indicated PT027 regulatory submissions will occur in the first half of 2022. •Zavegepant. InMarch 2021 , Biohaven announced that it enrolled the first patient in a Phase 2/3 clinical trial of oral zavegepant for the preventive treatment of migraine. Accordingly, per the agreement with Biohaven announced inAugust 2020 ,Royalty Pharma paid$100 million to Biohaven for the achievement of this milestone, bringing the total zavegepant funding to$250 million . InDecember 2021 , Biohaven announced positive topline results from the second pivotal clinical trial evaluating the safety and efficacy of intranasal zavegepant for the acute treatment of migraine in adults. The Phase 3 study achieved its co-primary regulatory endpoints of pain freedom and freedom of most bothersome symptom at 2 hours and showed broad efficacy by demonstrating statistically significant superiority to placebo across a total of 15 prespecified primary and secondary outcome measures. Biohaven plans to file an NDA for zavegepant with the FDA in the first half of 2022 and other countries thereafter. Non-GAAP Financial Results In addition to analyzing our results on a GAAP basis, management also reviews our results on a non-GAAP basis. There is no direct correlation between income from financial royalty assets and royalty receipts due to the nature of the accounting methodology applied for financial royalty assets. Further, income from financial royalty assets and the provision for changes in expected cash flows related to these financial royalty assets can be volatile and unpredictable. As a result, management places importance on royalty receipts as they are predictable and we use them as a measure of our operating performance. Refer to section titled "Non-GAAP Reconciliations" for additional discussion of management's use of non-GAAP measures as supplemental financial measures and reconciliations from the most directly GAAP comparable measures of Net cash provided by operating activities. Adjusted Cash Receipts is a measure calculated with inputs directly from the statements of cash flows and includes (1) royalty receipts by product: (i) Cash collections from royalty assets (financial assets and intangible assets), (ii) Other royalty cash collections, (iii) Distributions from equity method investees, plus (2) Proceeds from available for sale debt securities; less (1) Distributions to non-controlling interests, which represents contractual distributions of royalty receipts and proceeds from available for sale debt securities to our historical non-controlling interests related to the Legacy Investors Partnerships and RPSFT. Adjusted Cash Receipts is most directly comparable to the GAAP measure of Net cash provided by operating activities. Adjusted EBITDA and Adjusted Cash Flow are similar non-GAAP liquidity measures that are both most closely comparable to the GAAP measure, Net cash provided by operating activities. Adjusted EBITDA is important to our lenders and is defined under the Credit Agreement as Adjusted Cash Receipts less Payments for operating and professional costs. Payments for operating and professional costs are comprised of Payments for operating and professional costs and Payments for rebates from the statements of cash flows. 43 -------------------------------------------------------------------------------- ROYALTY PHARMA PLC NOTES TO THE CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED) Adjusted Cash Flow is defined as Adjusted EBITDA less (1) Development-stage funding payments - ongoing, (2) Development-stage funding payments - upfront and milestones, (3) Interest paid, net of Interest received, (4) Investments in equity method investees and (5) Other (including Derivative collateral posted, net of Derivative collateral received, and Termination payments on derivative instruments) plus (1) Contributions from non-controlling interests- R&D, all directly reconcilable to the statements of cash flows. Adjusted Cash Receipts and Adjusted Cash Flow are used by management as key liquidity measures in the evaluation of our ability to generate cash from operations. Both measures are an indication of the strength of the Company and the performance of the business. Management also uses Adjusted Cash Flow to compare its performance against non-GAAP adjusted net income used by companies in the biopharmaceutical industry. Adjusted EBITDA, as derived from Adjusted Cash Receipts, is used by our lenders to assess our ability to meet our financial covenants. 44 -------------------------------------------------------------------------------- ROYALTY PHARMA PLC NOTES TO THE CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED) The table below includes the royalty receipts and non-GAAP financial results for the three months endedMarch 31, 2022 and 2021 by product in order of contribution to royalty receipts for the three months endedMarch 31, 2022 (in thousands). For the Three Months Ended March 31, 2022 vs. 2021 Change Royalties 2022 2021 $ % Cystic fibrosis franchise (1)$ 201,882 $ 166,809 $ 35,073 21.0 % Tysabri 97,439 86,921 10,518 12.1 % Imbruvica 87,171 89,135 (1,964) (2.2) % Promacta 47,897 44,126 3,771 8.5 % Xtandi 43,395 41,045 2,350 5.7 % Januvia, Janumet, Other DPP-IVs (2) 35,682 35,761 (79) (0.2) % Tremfya 28,224 - 28,224 - % Nurtec ODT/Biohaven payment (3) 20,375 16,501 3,874 23.5 % Cabometyx/Cometriq 12,857 - 12,857 - % Farxiga/Onglyza 9,469 8,562 907 10.6 % Evrysdi 9,197 1,677 7,520 * Trodelvy 4,892 2,605 2,287 87.8 % Erleada 4,886 3,104 1,782 57.4 % Emgality 4,764 3,264 1,500 46.0 % Crysvita 4,712 3,588 1,124 31.3 % Orladeyo 4,426 12 4,414 * Prevymis 4,126 8,630 (4,504) (52.2) % Oxlumo 766 - 766 - % Other products (4) 88,871 137,738 (48,867) (35.5) % Total royalty receipts$ 711,031 $ 649,478 $ 61,553 9.5 % Distributions to non-controlling interests (106,385) (125,721) 19,336 (15.4) % Adjusted Cash Receipts (non-GAAP)$ 604,646 $ 523,757 $ 80,889 15.4 % Payments for operating and professional costs (48,902) (42,160) (6,742) 16.0 % Adjusted EBITDA (non-GAAP)$ 555,744 $ 481,597 $ 74,147 15.4 % Development-stage funding payments - ongoing (500) (2,641) 2,141 (81.1) % Development-stage funding payments - upfront - % and milestones (100,000) - (100,000) Interest paid, net (85,734) (62,952) (22,782) 36.2 % Investments in equity method investees (3,050) (8,714) 5,664 (65.0) % Contributions from non-controlling interests- (68.8) % R&D 624 1,997 (1,373) Adjusted Cash Flow (non-GAAP)$ 367,084 $ 409,287 $ (42,203) (10.3) % Weighted average Class A ordinary shares outstanding - diluted 607,201 607,148
*Percentage change is not meaningful.
(1)The cystic fibrosis franchise includes the following approved products: Kalydeco, Orkambi, Symdeko/Symkevi and Trikafta/Kaftrio. (2)Januvia, Janumet, Other DPP-IVs include the following approved products: Onglyza, Kombiglyze, Galvus, Eucreas and Nesina. The Other DPP-IVs are marketed by AstraZeneca, Novartis and Takeda. (3)Includes royalty receipts for Nurtec ODT of$4.8 million and$0.9 million for the three months endedMarch 31, 2022 and 2021, respectively, and quarterly redemptions of$15.6 million in 2022 and 2021 of the Series A Biohaven Preferred Shares (presented as Proceeds from available for sale debt securities on the statements of cash flows). (4)Other products primarily include royalty receipts on the following products: Bosulif (a product co-developed by our joint venture investee, Avillion I, for which receipts are presented as Distributions from equity method investees on the statements of cash flows), Cimzia, Entyvio, HIV franchise, IDHIFA, Letairis, Lexiscan, Mircera, Myozyme, Nesina, Soliqua, Tazverik and contributions from the Legacy SLP Interest. 45
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ROYALTY PHARMA PLC NOTES TO THE CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)
Adjusted Cash Receipts (non-GAAP)
Three Months Ended
Adjusted Cash Receipts increased by$80.9 million to$604.6 million in the three months endedMarch 31, 2022 compared to the three months endedMarch 31, 2021 , primarily driven by an increase of$72.6 million in royalty receipts from existing products, including the cystic fibrosis franchise, offset by a decline of$52.9 million from matured royalties, primarily the HIV franchise. Additionally, we received royalty receipts of$41.8 million in the three months endedMarch 31, 2022 from newly acquired assets, primarily Tremfya, Cabometyx/Cometriq and Oxlumo, The increase in Adjusted Cash Receipts also reflects a decline in distributions to non-controlling interests due to maturing royalties jointly owned by the legacy investors.
Below we discuss the key drivers of royalty receipts.
Royalty Receipts
•Cystic fibrosis franchise - Royalty receipts from the cystic fibrosis franchise, which includes Kalydeco, Orkambi, Symdeko/Symkevi and Trikafta/Kaftrio, which are marketed by Vertex for patients with certain mutations causing cystic fibrosis, increased by$35.1 million in the three months endedMarch 31, 2022 compared to the three months endedMarch 31, 2021 . The increase was primarily driven by the launch of Kaftrio in multiple additional countries outsidethe United States and the performance of Trikafta inthe United States , including its uptake in children 6 through 11 years old. •Tysabri - Royalty receipts from Tysabri, which is marketed by Biogen for the treatment of multiple sclerosis, increased by$10.5 million in the three months endedMarch 31, 2022 compared to the three months endedMarch 31, 2021 , primarily driven by continued global patient growth and positive channel dynamics inthe United States . •Imbruvica - Royalty receipts from Imbruvica, which is marketed by AbbVie and Johnson & Johnson for the treatment of blood cancers and chronic graft versus host disease, decreased by$2.0 million in the three months endedMarch 31, 2022 compared to the three months endedMarch 31, 2021 , primarily driven by a slower-than-anticipated market recovery from COVID-19 in chronic lymphocytic leukemia and increased share pressure from newer therapies inthe United States . This decline was partially offset by growth in regions outsidethe United States . •Promacta - Royalty receipts from Promacta, which is marketed by Novartis for the treatment of chronic immune thrombocytopenia purpura (ITP) and aplastic anemia, increased by$3.8 million in the three months endedMarch 31, 2022 compared to the three months endedMarch 31, 2021 . This growth was primarily driven by increased use in ITP and further uptake as first-line treatment for severe aplastic anemia inthe United States . •Xtandi - Royalty receipts from Xtandi, which is marketed by Pfizer and Astellas for the treatment of prostate cancer, increased by$2.4 million in the three months endedMarch 31, 2022 compared to the three months endedMarch 31, 2021 , primarily driven by demand across various prostate cancer indications. •Januvia, Janumet, Other DPP-IVs - Royalty receipts from the DPP-IVs for type 2 diabetes, which includes Januvia and Janumet, both marketed by Merck & Co., was relatively consistent in three months endedMarch 31, 2022 compared to the three months endedMarch 31, 2021 .
•Tremfya - Royalty receipts from Tremfya, which is marketed by Johnson & Johnson
for the treatment of plaque psoriasis and active psoriatic arthritis, were
•Nurtec ODT/Biohaven payment - Royalty receipts from Nurtec ODT, marketed by Biohaven and Pfizer for the acute and preventative treatment of migraine, increased by$3.9 million in the three months endedMarch 31, 2022 compared to the three months endedMarch 31, 2021 . In addition, we received$15.6 million in fixed payments from Biohaven related to the Series A Biohaven Preferred Shares during each of the three months endedMarch 31, 2022 and 2021. 46 --------------------------------------------------------------------------------ROYALTY PHARMA PLC NOTES TO THE CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED) •Cabometyx/Cometriq - Royalty receipts from Cabometyx/Cometriq, which is marketed by Exelixis, Ipsen and Takeda, were$12.9 million in the three months endedMarch 31, 2022 , primarily driven by uptake of Cabometyx in combination with Opdivo as a first-line treatment for patients with advanced renal cell carcinoma. We acquired the Cabometyx/Cometriq royalty inMarch 2021 .
Distributions to Non-Controlling Interests
Distributions to non-controlling interests decreased by$19.3 million to$106.4 million in the three months endedMarch 31, 2022 compared to the three months endedMarch 31, 2021 , which positively impacted Adjusted Cash Receipts. The decrease in distributions to non-controlling interests is primarily due to maturing royalties jointly owned by the legacy investors.
Adjusted EBITDA (non-GAAP)
Three Months Ended
Adjusted EBITDA increased by$74.1 million to$555.7 million in the three months endedMarch 31, 2022 compared to the three months endedMarch 31, 2021 as a result of the factors noted above in "Adjusted Cash Receipts (Non-GAAP)". Payments for operating and professional costs, the only adjustment between Adjusted Cash Receipts and Adjusted EBITDA, increased in three months endedMarch 31, 2022 , primarily driven by higher Operating and Personnel Payments due to increased cash receipts from royalty investments.
Adjusted Cash Flow (non-GAAP)
Three Months Ended
Adjusted Cash Flow decreased by$42.2 million to$367.1 million in the three months endedMarch 31, 2022 compared to the three months endedMarch 31, 2021 , primarily driven by upfront and milestone development-stage funding payments of$100.0 million to Cytokinetics to acquire a royalty on a development-stage product candidate and a$22.8 million increase in net interest paid in the three months endedMarch 31, 2022 due to the first interest payment on the 2021 Notes. The decrease in Adjusted Cash Flow was partially offset by the increases in "Adjusted Cash Receipts" and "Adjusted EBITDA" (non-GAAP) noted above and lower funding requirements by the Avillion Entities.
Non-GAAP Reconciliations
Adjusted Cash Receipts, Adjusted EBITDA and Adjusted Cash Flow are non-GAAP measures presented as supplemental measures to our GAAP financial performance. These non-GAAP financial measures exclude the impact of certain items and therefore have not been calculated in accordance with GAAP. In each case, because our operating performance is a function of our liquidity, the non-GAAP measures used by management are presented and defined as supplemental liquidity measures. We caution readers that amounts presented in accordance with our definitions of Adjusted Cash Receipts, Adjusted EBITDA, and Adjusted Cash Flow may not be the same as similar measures used by other companies. Not all companies and analysts calculate the non-GAAP measures we use in the same manner. We compensate for these limitations by using non-GAAP financial measures as supplements to GAAP financial measures and by presenting the reconciliations of the non-GAAP financial measures to their most comparable GAAP financial measures, in each case being Net cash provided by operating activities. We believe that Adjusted Cash Receipts and Adjusted Cash Flow provide meaningful information about our operating performance because the business is heavily reliant on its ability to generate consistent cash flows and these measures reflect the core cash collections and cash charges comprising our operating results. Management strongly believes that our significant operating cash flow is one of the attributes that attracts potential investors to our business. 47 --------------------------------------------------------------------------------ROYALTY PHARMA PLC NOTES TO THE CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED) In addition, we believe that Adjusted Cash Receipts and Adjusted Cash Flow help identify underlying trends in the business and permit investors to more fully understand how management assesses the performance of the Company, including planning and forecasting for future periods. Adjusted Cash Receipts and Adjusted Cash Flow are used by management as key liquidity measures in the evaluation of the Company's ability to generate cash from operations. Both measures are an indication of the strength of the Company and the performance of the business. Management uses Adjusted Cash Receipts and Adjusted Cash Flow when considering available cash, including for decision-making purposes related to funding of acquisitions, voluntary debt repayments, dividends and other discretionary investments. Further, these non-GAAP financial measures help management, the audit committee and investors evaluate our ability to generate liquidity from operating activities. Management believes that Adjusted EBITDA is an important non-GAAP measure in analyzing our liquidity and is a key component of certain material covenants contained within the Company's credit agreement. Noncompliance with the interest coverage ratio and leverage ratio covenants under the credit agreement could result in our lenders requiring the Company to immediately repay all amounts borrowed. If we cannot satisfy these financial covenants, we would be prohibited under our credit agreement from engaging in certain activities, such as incurring additional indebtedness, paying dividends, making certain payments and acquiring and disposing of assets. Consequently, Adjusted EBITDA is critical to the assessment of our liquidity. Management uses Adjusted Cash Flow to evaluate its ability to generate cash and performance of the business and to evaluate the Company's performance as compared to its peer group. Management also uses Adjusted Cash Flow to compare its performance against non-GAAP adjusted net income measures used by many companies in the biopharmaceutical industry, even though each company may customize its own calculation and therefore one company's metric may not be directly comparable to another's. We believe that non-GAAP financial measures, including Adjusted Cash Flow, are frequently used by securities analysts, investors, and other interested parties to evaluate companies in our industry. The non-GAAP financial measures used in this Quarterly Report on Form 10-Q have limitations as analytical tools, and you should not consider them in isolation or as a substitute for the analysis of our results as reported under GAAP. We have provided a reconciliation of each non-GAAP financial measure to the most directly comparable GAAP financial measure, in each case being Net cash provided by operating activities below. To arrive at Adjusted Cash Receipts, we start with the GAAP line item, Net cash provided by operating activities, and adjust for the following items from the statements of cash flows: to add back (1) Proceeds from available for sale debt securities (redemption of Biohaven Preferred Shares), which are cash inflows that management believes are derived from royalties and form part of our core business strategy, (2) Distributions from equity method investees which are classified as cash inflows from investing activities, (3) Interest paid, net of Interest received, (4) Development-stage funding payments, (5) Payments for operating and professional costs, (6) Payments for rebates and (7) Termination payments on derivative instruments, and to deduct (1) Distributions to non-controlling interests, which represents distributions to our historical non-controlling interests related to the Legacy Investors Partnerships and RPSFT, and (2) Derivative collateral posted or (received), net, both of which are excluded when management assesses its operating performance through cash collections, or, Adjusted Cash Receipts. To arrive at Adjusted EBITDA, we start with Net cash provided by operating activities and adjust for the following items from the statements of cash flows: to add back (1) Proceeds from available for sale debt securities (redemption of Biohaven Preferred Shares), (2) Distributions from equity method investees which are classified as cash inflows from investing activities, (3) Interest paid, net of Interest received, (4) Development-stage funding payments and (5) Termination payments on derivative instruments, and to deduct (1) Distributions to non-controlling interests and (2) Derivative collateral posted or (received), net. To arrive at Adjusted Cash Flow, we start with Net cash provided by operating activities and adjust for the following items from the statements of cash flows: to add back (1) Proceeds from available for sale debt securities (redemption of Biohaven Preferred Shares), (2) Distributions from equity method investees classified as cash inflows from investing activities and (3) Contributions from non-controlling interests-R&D, and to deduct (1) Distributions to non-controlling interests and (2) Investments in equity method investees. This is intended to present an Adjusted Cash Flow measure that is representative of cash generated from the broader business strategy of acquiring royalty-generating assets that are available for reinvestment and for discretionary purposes. 48 --------------------------------------------------------------------------------ROYALTY PHARMA PLC NOTES TO THE CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED) (in thousands) For the Three Months Ended March 31, 2022 2021 Net cash provided by operating activities (GAAP)$ 460,270 $ 526,100 Adjustments: Proceeds from available for sale debt securities (1), (2) 15,625 15,625 Interest paid, net (2) 85,734 62,952 Development-stage funding payments - ongoing (3) 500 2,641 Development-stage funding payments - upfront and milestones (3) 100,000 - Payments for operating and professional costs 48,902 42,160 Distributions to non-controlling interests (2) (106,385) (125,721) Adjusted Cash Receipts (non-GAAP)
Net cash provided by operating activities (GAAP)$ 460,270 $ 526,100 Adjustments: Proceeds from available for sale debt securities (1), (2) 15,625 15,625 Interest paid, net (2) 85,734 62,952 Development-stage funding payments - ongoing (3) 500 2,641 Development-stage funding payments - upfront and milestones (3) 100,000 - Distributions to non-controlling interests (2) (106,385) (125,721) Adjusted EBITDA (non-GAAP)
Net cash provided by operating activities (GAAP)$ 460,270 $ 526,100 Adjustments: Proceeds from available for sale debt securities (1), (2) 15,625 15,625 Contributions from non-controlling interests-R&D (2) 624 1,997 Distributions to non-controlling interests (2) (106,385) (125,721) Investments in equity method investees (2), (4) (3,050) (8,714) Adjusted Cash Flow (non-GAAP)
(1) Receipts from the quarterly redemption of the Series A Biohaven Preferred Shares are presented as Proceeds from available for sale debt securities on the statements of cash flows. (2) The table below shows the line item for each adjustment and the direct location for such line item on the statements of cash flows.
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